Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery

Bausch & Lomb Incorporated522 enrolled

Overview

The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo cataract extraction and intraocular lens implantation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

522

Conditions

Pain Inflammation

Interventions

bromfenac ophthalmic solutionDRUG

placebo comparatorDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Scheduled for unilateral cataract surgery with no other ophthalmic surgical procedures planned during cataract surgery * Agree to return for all required visits * Agree to avoid disallowed medications Exclusion Criteria: * Known hypersensitivity to bromfenac and salicylates

Locations (1)

Unnamed facility

Irvine, California, United States

Outcomes

Primary Outcomes

Reduction of ocular inflammation

Secondary Outcomes

Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.